Janssen brings psoriasis therapy guselkumab to the EMA

Janssen brings psoriasis therapy guselkumab to the EMA

Janssen has filed its potential new psoriasis therapy guselkumab with the European Medicines Agency, hot on the heels of the drug’s submission in the US.

Guselkumab is a human monoclonal antibody that targets the protein interleukin (IL)-23, which is known to play a key role in the development of immune-mediated inflammatory diseases.

Around 14 million people in Europe suffer from psoriasis, a chronic, autoimmune inflammatory disorder that results in the overproduction of skin cells, characterised by raised, inflamed, scaly, red lesions, or plaques, which can cause itching, discomfort and pain.

The drug targets moderate to severe forms of the disease, which accounts for around 20 percent of all cases.

The filing is based on safety and efficacy data gathered from four studies, the Phase III VOYAGE 1, VOYAGE 2 and NAVIGATE trials and the Phase II X-PLORE study.

At week 24, the proportion of patients who achieved a PASI 90 response was significantly higher in the guselkumab group compared with the adalimumab group (80.2 percent vs. 53.0 percent, respectively), and higher levels of skin clearance in those taking Janssen’s drug continued through weeks 24 and 48, the firm said.

On the safety side, serious adverse events were reported in 1.7 percent of patients receiving placebo, 2.4 percent of patients receiving guselkumab and 1.8 percent of patients receiving Humira, while the proportions of patients reporting at least one AE were comparable between the two groups at 73.9 percent and 74.5 percent, respectively.

Despite the recent swell in experimental and newly approved psoriasis therapies, such as Novartis Cosentyx (secukinumab) and Lilly’s Taltz (ixekizumab), it is widely anticipated that guselkumab will achieve blockbuster status should it make it to market on both sides of the Atlantic.